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Articles from Drug Injury Watch

The Adverse Drug Reactions And Medication Errors That Require Hospital Care Most Often 2007-07-13 16:40:00 Some Lessons Learned From A "Top 10" Drug Errors Session At The American Pharmacists Association 2007 Annual Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The American Pharmacists Association (APhA) Annual Meeting was held in Atlanta, Georgia earlier this year.  A large number of the 7000 attendees took time out of their busy schedules for one of the meeting's most popular sessions, "The Top 10 Adverse Drug Reactions and Medication Errors", which was presented by Matthew Grissinger, RPh, FASCP, a medication safety analyst with the Institute for Safe Medication Practices (ISMP). As reported in a Medscape.com article by Kathryn L. Hahn, PharmD:Grissinger first referred to a study that identified the 10 drugs most commonly implicated in adverse events requiring treatment in a hospital emergency department (ED). The study also documented the frequency with which each of the 10 drugs was involved: 1. Insulin (8%);2. Anticoagulants (6.2%);3. Amoxicillin (s ...

The Adverse Drug Reactions And Medication Errors That Require Hospital Care Most Often 2007-07-13 16:40:00 Some Lessons Learned From A "Top 10" Drug Errors Session At The American Pharmacists Association 2007 Annual Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The American Pharmacists Association (APhA) Annual Meeting was held in Atlanta, Georgia earlier this year.  A large number of the 7000 attendees took time out of their busy schedules for one of the meeting's most popular sessions, "The Top 10 Adverse Drug Reactions and Medication Errors", which was presented by Matthew Grissinger, RPh, FASCP, a medication safety analyst with the Institute for Safe Medication Practices (ISMP). As reported in a Medscape.com article by Kathryn L. Hahn, PharmD:Grissinger first referred to a study that identified the 10 drugs most commonly implicated in adverse events requiring treatment in a hospital emergency department (ED). The study also documented the frequency with which each of the 10 drugs was involved: 1. Insulin (8%);2. Anticoagulants (6.2%);3. Amoxicillin (s ...

Bisphosphonate-Induced Osteonecrosis Of The Jaw: Medical Journal Updates 2007-07-09 17:14:06 Overview Of What Is Known About Fosamax And Other Bisphosphonates Related To This Serious Jaw Bone Problem (Posted by Tom Lamb at DrugInjuryWatch.com) In recent years several studies have found an association between the use ofbisphosphonates, including Fosamax (alendronate), and osteonecrosis of the jaw (ONJ). Basically, ONJ is a condition in which poor blood supply to the area leads to jaw bone death or deterioration. The July 2007 edition of Current Opinion in Oncology includes a review article, "Osteonecrosis of the jaw related to the use of bisphosphonates", that attempts to present a snapshot of the growing medical literature about bisphosphonate-induced osteonecrosis of the jaw. The Medline Abstract for this July 2007 bisphosphonate - ONJ article includes these Recent Findings points: Diagnostic criteria and a staging system for osteonecrosis of the jaw have been proposed, and histomorphologic analysis has confirmed osteonecrosis of the jaw as a proper disease, di ...

Bisphosphonate-Induced Osteonecrosis Of The Jaw: Medical Journal Updates 2007-07-09 17:14:06 Overview Of What Is Known About Fosamax And Other Bisphosphonates Related To This Serious Jaw Bone Problem (Posted by Tom Lamb at DrugInjuryWatch.com) In recent years several studies have found an association between the use ofbisphosphonates, including Fosamax (alendronate), and osteonecrosis of the jaw (ONJ). Basically, ONJ is a condition in which poor blood supply to the area leads to jaw bone death or deterioration. The July 2007 edition of Current Opinion in Oncology includes a review article, "Osteonecrosis of the jaw related to the use of bisphosphonates", that attempts to present a snapshot of the growing medical literature about bisphosphonate-induced osteonecrosis of the jaw. The Medline Abstract for this July 2007 bisphosphonate - ONJ article includes these Recent Findings points: Diagnostic criteria and a staging system for osteonecrosis of the jaw have been proposed, and histomorphologic analysis has confirmed osteonecrosis of the jaw as a proper disease, di ...

Latest Avandia Heart Risk Findings Reported In July 5, 2007 NEJM Edition 2007-07-06 11:20:38 Avandia Seems Associated With Increased Rate Of Heart Failure; Less Clear Whether Glaxo's Diabetes Drug Causes Heart Attacks, Other Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) In the July 5, 2007 edition of The New England Journal of Medicine (NEJM) there are several editorials of interest to those doctors and patients who are concerned about the heart safety of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone). Before we get to the editorials, from the July 5 NEJM, a short item entitled "Rosiglitazone Evaluated for Cardiovascular Outcomes" provides a good overview of the situation at present:Meta-analyses suggest that the thiazolidinedione [Avandia], used in the treatment of type 2 diabetes, may increase the risk of myocardial infarction and death from cardiovascular causes. This interim analysis of an ongoing noninferiority trial of rosiglitazone is inconclusive but does not exclude cardiotoxicity. Because patients with diabetes are alread ...

Latest Avandia Heart Risk Findings Reported In July 5, 2007 NEJM Edition 2007-07-06 11:20:38 Avandia Seems Associated With Increased Rate Of Heart Failure; Less Clear Whether Glaxo's Diabetes Drug Causes Heart Attacks, Other Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) In the July 5, 2007 edition of The New England Journal of Medicine (NEJM) there are several editorials of interest to those doctors and patients who are concerned about the heart safety of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone). Before we get to the editorials, from the July 5 NEJM, a short item entitled "Rosiglitazone Evaluated for Cardiovascular Outcomes" provides a good overview of the situation at present:Meta-analyses suggest that the thiazolidinedione [Avandia], used in the treatment of type 2 diabetes, may increase the risk of myocardial infarction and death from cardiovascular causes. This interim analysis of an ongoing noninferiority trial of rosiglitazone is inconclusive but does not exclude cardiotoxicity. Because patients with diabetes are alread ...

Black-Box Warning About Anaphylaxis Being Put On Asthma Drug Xolair 2007-07-03 13:32:34 Potentially Deadly Allergic Reaction Occurs Twice As Often As Previously Stated On Medication's Prior Label (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA announced on July 2, 2007 that the package insert, or label, for the asthma drug Xolair now has a black-box warning about anaphylaxis, a potentially fatal allergic reaction which can involve shortness of breath, rash, wheezing, and low blood pressure. Xolair, which is given as an injection, was approved in June 2003 by the FDA for the treatment of moderate to severe asthma in adults and children older than 12 years of age. The prior Xolair label's warning about anaphylaxis stated that this allergic reaction occurs in about one in 1,000 patients taking this asthma medication. The black-box warning added to the new Xolair label states that cases of anaphylaxis were seen in roughly two out of 1,000 patients, or twice as many as the label previously warned. A MedWatch Safety Information Alert about Xolair issued in Februar ...

Black-Box Warning About Anaphylaxis Being Put On Asthma Drug Xolair 2007-07-03 13:32:34 Potentially Deadly Allergic Reaction Occurs Twice As Often As Previously Stated On Medication's Prior Label (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA announced on July 2, 2007 that the package insert, or label, for the asthma drug Xolair now has a black-box warning about anaphylaxis, a potentially fatal allergic reaction which can involve shortness of breath, rash, wheezing, and low blood pressure. Xolair, which is given as an injection, was approved in June 2003 by the FDA for the treatment of moderate to severe asthma in adults and children older than 12 years of age. The prior Xolair label's warning about anaphylaxis stated that this allergic reaction occurs in about one in 1,000 patients taking this asthma medication. The black-box warning added to the new Xolair label states that cases of anaphylaxis were seen in roughly two out of 1,000 patients, or twice as many as the label previously warned. A MedWatch Safety Information Alert about Xolair issued in Februar ...

FDA Letter Concerning Sybmyax May Result In More Zyprexa Lawsuits For Lilly 2007-06-29 17:00:18 According To Bloomberg Report, FDA Wants Information About Weight Gain And High Levels Of Blood Sugar Added To Zyprexa Label (Posted by Tom Lamb at DrugInjuryWatch.com) On June 29, 2007 Bloomberg published an article by its reporters Rob Waters and Margaret Cronin Fisk about a March 2007 "approvable letter" that the FDA sent to Eli Lilly & Co. on its drug Symbyax, which is a combination of Lilly's antipsychotic drug Zyprexa and the antidepressant drug Prozac. According to this June 29 Bloomberg article, the March 2007 letter stated that the FDA "would delay the approval of Symbyax for depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label."  The reporters said in their article Bloomberg had obtained a copy of this letter by Thomas Laughren, director of the FDA's division of psychiatry products, although "the letter hasn't been publicly released." Bloomberg's June 29 article p ...

Safety Of Avandia Discussed At Diabetes Meeting By Doctors Nissen, Buse, And Home 2007-06-26 11:04:11 Issues Include Publishing Of May 2007 NEJM Article And Whether To Keep Diabetic Patients On Avandia (Posted by Tom Lamb at DrugInjuryWatch.com) A lively discussion during a session about Avandia was the highlight of the American Diabetes Association's annual meeting in Chicago on June 25, 2007 according to news reports.  During a panel discussion of this session -- which was added at the last minute in order to address Dr. Steven Nissen's "meta-analysis" of Avandia data that was published in May 2007 by The New England Journal of Medicine -- some of the 13,000 doctors and researchers in attendance heard Dr. Nissen defend his controversial Avandia study while other prominent doctors took issue with it. According to a June 25, 2007 report from CNNMoney.com:... Dr. Philip Home, a professor of diabetes at Newcastle University in the United Kingdom and a member of the steering committee for one of the Avandia studies included in Nissen's analysis, criticized the way Nis ...